Rosin, fumarated, reaction products with glycerol and pentaerythritol

Endpoint summary

Description of key information

Capable of causing sensitisation by skin contact.

Not expected to induce or elicit respiratory sensitization, with low potential for exposure due to low volatility.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Adequate information exists to characterise the skin sensitisation potential of Rosin adduct esters. These are formed after modification of rosin with either fumaric acid or maleic anhydride followed by esterification with glycerol and/or pentaerythritol, and hence the adduct ester products therefore exhibit close structural similarities. The available data includes results of tests conducted using Resin acids and rosin acids, fumarated, esters with pentaerythritol, Resin acids and rosin acids, maleated, esters with pentaerythritol and Rosin, fumarated, reaction products with glycerol and pentaerythritol. This information is summarised below.

In a LLNA study evaluating the sensitisation potential of Resin acids and rosin acids, fumarated, esters with pentaerythritol, groups of mice were given daily applications of 0%, 10%, 25%, or 50% (w/v) SYLVATAC RE100S in butanone (Safepharm Laboratories Limited, 2003a). Test concentrations were applied to the dorsal surface of each ear for 3 consecutive days. A control group received the vehicle only in the same manner. On Day 5, 3HTdR was injected into the tail vein, the auricular lymph nodes collected 5 hr later, and a single cell suspension prepared. 3HTdR incorporation by the cells was determined, and the Stimulation Index (SI) calculated for each dose of the test substance. The pooled Stimulation Index was 2.63, 4.07, and 3.45, respectively. Based on the results, SYLVATAC RE100S (Resin acids and rosin acids, fumarated, esters with pentaerythritol) was a skin sensitizer in mice in an OECD 429 compliant study.

In another LLNA test on Resin acids and rosin acids, fumarated, esters with pentaerythritol, the test material was applied to the dorsal surface of the ear of CBA/Ca strain mice (Harlan Laboratories Ltd., 2010a). The method was designed to meet the requirements of OECD 429 and EU Method B.42. Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 50% w/w, this concentration was selected as the highest dose investigated in the main test. Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a solution in dimethyl formamide at concentrations of 50%, 25% or 10% w/w. A further group of four animals was treated with dimethyl formamide alone. The concentration of test material expected to cause a 3-fold increase in3HTdR incorporation (EC3value) was calculated to be 32.0%. The test material was considered to be a sensitiser under the conditions of the test.

In a skin sensitization study using the LLNA, groups of mice were given daily applications of 0%, 0.25%, 2.5%, or 25% (w/v) 40-WP701/042 (Resin acids and rosin acids, maleated, esters with pentaerythritol) in butanone which was applied to the dorsal surface of each ear for 3 consecutive days (Safepharm Laboratories Limited, 2002). A control group received the vehicle only in the same manner. On Day 5, 3HTdR was injected into the tail vein, the auricular lymph nodes collected 5 hr later, and a single cell suspension prepared. 3HTdR incorporation by the cells was determined, and the Stimulation Index (SI) calculated for each dose of the test substance. The pooled Stimulation Index was 0.39, 1.34, and 3.30, respectively. Based on the results, 40-WP701/042 (Resin acids and rosin acids, maleated, esters with pentaerythritol) was a skin sensitizer in mice in an OECD 429 compliant study.

In a skin sensitization study using the LLNA, groups of mice were given daily applications of 0%, 0.25%, 2.5%, or 25% (w/v) 40-AVL 283/082 (Resin acids and rosin acids, maleated, esters with pentaerythritol) in butanone which was applied to the dorsal surface of each ear for 3 consecutive days (Safepharm Laboratories Limited, 2003b). A control group received the vehicle only in the same manner. On Day 5, 3HTdR was injected into the tail vein, the auricular lymph nodes collected 5 hr later, and a single cell suspension prepared. 3HTdR incorporation by the cells was determined, and the Stimulation Index (SI) calculated for each dose of the test substance. The pooled Stimulation Index was 1.34, 1.41, and 3.83, respectively. Based on the results, 40-AVL 283/082 (Resin acids and rosin acids, maleated, esters with pentaerythritol) was a skin sensitizer in mice in an OECD 429 compliant study.

In a skin sensitization study using the LLNA, groups of mice were given daily applications of 0%, 0.25%, 2.5%, or 25%(w/v) 40-AVL 284/082 (Resin acids and rosin acids, maleated, esters with pentaerythritol; acid value 35) in acetone/olive oil 4:1which was applied to the dorsal surface of each ear for 3 consecutive days (Safepharm Laboratories Limited, 2003c). A control group received the vehicle only in the same manner. On Day 5, 3HTdR was injected into the tail vein, the auricular lymph nodes collected 5 hr later, and a single cell suspension prepared. 3HTdR incorporation by the cells was determined, and the Stimulation Index (SI) calculated for each dose of the test substance. The pooled Stimulation Index was1.34, 1.41, and 3.83, respectively. Based on the results, 40-AVL 284/082 (Resin acids and rosin acids, maleated, esters with pentaerythritol; acid value 35) was a skin sensitizer in mice in an OECD 429 compliant study.

In a skin sensitization study using the LLNA, groups of mice were given daily applications of 0%, 10%, 25%, or 50% (w/v) Sylvatac RAZ 115 (Rosin, fumarated, reaction products with glycerol and pentaerythritol) in butanone which was applied to the dorsal surface of each ear for 3 consecutive days (Safepharm Laboratories Limited, 2003d). A control group received the vehicle only in the same manner. On Day 5, 3HTdR was injected into the tail vein, the auricular lymph nodes collected 5 hr later, and a single cell suspension prepared. 3HTdR incorporation by the cells was determined, and the Stimulation Index (SI) calculated for each dose of the test substance. The pooled Stimulation Index was 4.37, 4.37, and 4.73, respectively. Based on the results, Sylvatac RAZ 115 (Rosin, fumarated, reaction products with glycerol and pentaerythritol) was a skin sensitizer in mice in an OECD 429 compliant study.

One skin sensitization study with negative results was identified for Resin acids and rosin acids, fumarated, esters with pentaerythritol. This is a Guinea Pig Maximisation Test conducted according to OECD 406 guideline (Huntingdon Research Centre Ltd, 1992). Twenty female guinea pigs were induced with Rosin, fumarated, ester with pentaerythritol at 7.5% w/w in Alembicol D by intradermal injections and an additional 20 animals were induced with 83.3% w/w in Alembicol D by epicutaneous administration. Along with the test animals, a group of 20 control animals, previously not induced were challenged dermally with 41.65% or 83.3% w/w. Treated animals induced similar dermal response to controls when challenged at 83.3% and 41.65% w/w in Alembicol D through epicutaneous route. Therefore, under the conditions of this study the test material is not a sensitiser.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Not expected to induce or elicit respiratory sensitization, with low potential for exposure due to low volatility.

Justification for classification or non-classification

Classified for skin sensitisation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).